FDA Clears Science 37’s DTP Site in Phase 3 Asthma Trial Inspection

Science 37, a leader in enhancing patient access to clinical trials, announced the successful completion of its second US FDA inspection, reaffirming the quality of its Direct-to-Patient Site for clinical research. The inspection resulted in a no action indicated categorization, with no objectionable conditions noted and no Form 483 issued.

Led by Science 37’s internal quality assurance and compliance team, the inspection focused on the company’s role in a registrational phase 3 asthma study, which Science 37 contributed 28 per cent of the total patient enrollment. The US FDA evaluated internal processes, technology, data integrity, patient safety, protocol adherence, principal investigator oversight, and all associated documentation.

This marks Science 37’s second successful US FDA inspection within the last 13 months, following a similar review in March 2024 that assessed three pivotal phase 3 trials.

“The results of this US FDA inspection further validate the strength of our Direct-to-Patient Site in maintaining the highest regulatory standards while transforming clinical trial access,” said Irena Lambridis, VP and Head of Quality Assurance & Compliance at Science 37. “By expanding reach and ensuring rigorous oversight, we are helping sponsors accelerate timelines, optimize data integrity, and bring life-changing treatments to patients faster.”

“As an investigator for Science 37, I have complete oversight of study visits through our telemedicine platform and close coordination with our research-grade nurses,” said Dr. Debra Weinstein, VP of Internal Medicine at Science 37. “Our Direct-to-Patient Site enables us to conduct comprehensive assessments and ensure protocol adherence remotely - delivering the quality and compliance validated by this US FDA inspection.”

Science 37’s Direct-to-Patient Site empowers clinical trial sponsors to reach 100 per cent of their target patient population by bringing research directly to patients’ homes. With nationwide reach, investigators with 50-state medical licensure, and research-grade nursing, the site enhances enrollment speed while delivering high-quality results.

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